Lower risk Medical device recall · FDA · Published November 19, 2019

Angiodynamics OARTRAC Prostate Implantation Balloon Kit: Accuracy Readings May Be Off

Angiodynamics recalls prostate immobilization balloon kits with catalog number ORB-60F due to potential inaccurate radiation therapy readings. Affected units were sold with specific lot numbers and UDI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0709-2020Medical device Angiodynamics ›

Lower-risk recall

May result in readings outside of the expected accuracy range.

Take action

Contact the company

Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619

✎ GovInfoNow plain-language explainer

Angi: OARTRAC prostate immobilization balloon kits (catalog ORB-60F) may give inaccurate radiation therapy readings. This could affect cancer treatment planning if not corrected. Read more at govinfonow.com/recall/66484-angiodynamics-oartrac-prostate-implantation-balloon-kit-accuracy-readings-may-be.

Source Summary by GovInfoNow · govinfonow.com/recall/66484-angiodynamics-oartrac-prostate-implantation-balloon-kit-accuracy-readings-may-be · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0709-2020

Cite this page

“Angiodynamics OARTRAC Prostate Implantation Balloon Kit: Accuracy Readings May Be Off.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66484-angiodynamics-oartrac-prostate-implantation-balloon-kit-accuracy-readings-may-be. Based on FDA recall #Z-0709-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0709-2020%22&limit=1).

Angiodynamics, Inc. recalled its OARTRAC Prostate Immobilization Endorectal Balloon Device Kit on Nov. 19, 2019, according to the FDA. The device may result in readings outside of the expected accuracy range.

How to tell if you have it

Brand: Angiodynamics
Product: OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT
Catalog Number: ORB-60F
Lot Numbers: 114290, 114935
UDI: 00851546007066

The hazard

The recalled pre-calibrated PSD sensors may result in readings outside of the expected accuracy range. The device is intended for use during cancer treatments to measure photon and electron radiation therapy.

Context

GovInfoNow's records show Angiodynamics, Inc. has had 18 other recalls on record since June 5, 2017. Other recent recalls of similar products include the Soft-Vu Angiographic Catheter Recall (March 3, 2026), the Angiodynamics IsoLoc Prostate Balloon Kit Mislabeled with Incorrect Fill Volume (Feb. 4, 2025), and the Angiodynamics Auryon Laser System Recall (Nov. 25, 2024).

How to tell if you have this one

Check for catalog number ORB-60F on the kit. Lot numbers 114290 or 114935 and UDI code 00851546007066 are associated with this recall.

Brand
Angiodynamics
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.

Recall number	Product, codes & lots	Quantity
Z-0709-2020	OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.; Lot Numbers: 114290, 114935 UDI 00851546007066	160 units
Z-0710-2020	OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.; Lot Numbers: 025-001-055-A-003, 025-001-055-A-005, 025-001-055-A-007, 025-001-055-A-008 UDI: 00851546007196	4 units
Z-0711-2020	MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.; Lot Numbers: 119788 UDI: 00851546007615	36 units
Z-0712-2020	MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.; Lot Numbers: 118881, 118929, 119750 UDI:00851546007714	60 units
Z-0713-2020	MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body.; Lot Numbers: 106020, 106030, 119400 UDI: 00851546007141	48 units

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for catalog number ORB-60F, lot numbers 114290 or 114935, and UDI code 00851546007066.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Georgia, Massachusetts, New Jersey, New York, Ohio, Pennsylvania.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Nov 19, 2019Firm started the recall
Dec 19, 2019FDA classified it Class II
Dec 25, 2019Published in FDA’s Enforcement Report
Oct 26, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66484-angiodynamics-oartrac-prostate-implantation-balloon-kit-accuracy-readings-may-be">Angiodynamics OARTRAC Prostate Implantation Balloon Kit: Accuracy Readings May Be Off (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0709-2020 (November 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0709-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.